Clinical Trial 19101

Cancer Type: Thoracic
Interventions:BMS-936558 (Nivolumab); BMS-986205; Nivolumab

Study Type: Treatment
Phase of Study: Phase I/II
Investigators:

  • Scott Antonia

Overview

Study Title

A Phase 1/2a Study of BMS-986205 Administered in Combination with Nivolumab anti-PD-1 Monoclonal Antibody) and in Combination with Both Nivolumab and Ipilimumab (anti-CTLA-4 Monoclonal Antibody) in Advanced Malignant Tumors

Summary

The purpose of the study is to determine safety and effectiveness of experimental medication BMS-986205 when combined with Nivolumab and in combination with both Nivolumab and Ipilimumab in patients with cancers that are advanced or have spread. Pharmacokinetics and pharmacodynamics of BMS-986205 when combined with Nivolumab and in combination with Nivolumab and Ipilimumab in this patient population will also be assessed.

Objective

To investigate the anti-tumor activity of BMS-986205 administered in combination with nivolumab in distinct cohorts of subjects with advanced malignant tumors. To evaluate the safety and tolerability of BMS-986205 in combination with nivolumab in subjects with advanced malignant tumors. Secondary Objectives: To characterize the pharmacokinetics (PK) of BMS-986205 administered alone and in combination with nivolumab. To investigate the anti-tumor activity of BMS-986205 administered in combination with nivolumab in dose escalation and clinical pharmacology substudies. To characterize the pharmacodynamic activity of BMS-986205 administered alone and in combination with nivolumab. To characterize the immunogenicity of nivolumab when administered in combination with BMS-986205.

Inclusion Criteria

  • During dose escalation, subjects with advanced solid tumors that have progressed following at least one standard regimen
  • During cohort expansion, participants with advanced cancer that either have received at least one prior therapy or are treatment naive, depending on the specified tumor type
  • Participants must have measurable disease
  • Must consent to provide previously collected tumor tissue and a tumor biopsy during screening
  • At least 4 weeks since any previous treatment for cancer
  • Must be able to swallow pills or capsules
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1

  • Exclusion Criteria

  • Active or chronic autoimmune diseases
  • Uncontrolled or significant cardiovascular disease
  • History of any chronic Hepatitis, active Hepatitis B or C, human immunodeficiency virus (HIV), or acquired immune deficiency syndrome (AIDS)
  • Chronic hepatitis: Positive test for Hepatitis B virus surface antigen or Hepatitis C antibody (except for potential participants with hepatocellular carcinoma)
  • Active central nervous system (CNS) metastases and CNS metastases as the only sites of disease
  • Active infection
  • Other protocol defined inclusion/exclusion criteria could apply